Hyperglycemia

Corcept Announces Positive Results From Open-Label Portion of Pivotal Phase 3 GRACE Trial in Patients With Cushing’s Syndrome

Retrieved on: 
Monday, April 22, 2024
GRACE, Hyperglycemia, University, Patient, Syndrome, SBP, Adrenal insufficiency, Safety, NDA, Waist, Ann Arbor, Michigan, MD, Doctor of Philosophy, Vaginal bleeding, DSM-IV codes, Doctor of Pharmacy, Diabetes, Hypertension, Metabolism, Internal medicine, Endocrinology, Division, Deficit spending, DBP, Pharmaceutical industry

In the “open-label” phase, 152 patients with Cushing’s syndrome and either hypertension, hyperglycemia or both received relacorilant for 22 weeks.

Key Points: 
  • In the “open-label” phase, 152 patients with Cushing’s syndrome and either hypertension, hyperglycemia or both received relacorilant for 22 weeks.
  • GRACE’s primary endpoint is maintenance of blood pressure control in the “randomized withdrawal” phase, with maintenance of glycemic control as the key secondary endpoint.
  • Other key secondary and exploratory endpoints in the randomized withdrawal phase include changes in weight, waist circumference, cognitive impairment and Cushing’s Quality of Life score.
  • Patients in the open-label phase exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other key secondary and exploratory endpoints.

Response Pharmaceuticals’ Drug Candidate for the Treatment of Antipsychotic-Induced Weight Gain (AIWG) Achieves Primary Endpoint in Phase 1b Clinical Trial

Retrieved on: 
Tuesday, April 23, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Fitness & Nutrition, Clinical Trials, Hyperglycemia, Weight gain, Safety, Bipolar disorder, DSM-IV codes, Neuroscience, MD, Human, Depression, Life, Triglyceride, Schizophrenia, Hyperlipidemia, Obesity, Psychiatry, Patient, Olanzapine, Harvard Medical School, AUC, Medication, Quality of life, Pharmaceutical industry

“Antipsychotic medications are essential treatments that help millions of patients live better lives, but can be associated with rapid weight gain and obesity.

Key Points: 
  • “Antipsychotic medications are essential treatments that help millions of patients live better lives, but can be associated with rapid weight gain and obesity.
  • Subjects in the RDX-002 cohort met the primary endpoint for efficacy, lowering postprandial triglycerides (ppTGs).
  • While exploratory, these findings support results seen in other trials where RDX-002 has demonstrated an impact on body weight, hyperlipidemia and hyperglycemia.
  • “Treatment with the iMTP-inhibitor RDX-002 significantly reduced ppTGs and blunted the weight gain in OLAN-treated subjects indicating a potential role in the treatment and prevention of AIWG.

Glytec Announces Support for Landmark New CMS Measures to Improve Diabetes Reporting

Retrieved on: 
Thursday, April 18, 2024
FDA, Congress, Hyperglycemia, CMS, HHS, Diabetes, Insulin, News, Hospital, UC Davis Medical Center, AHRQ, Partnership, Agency, Software as a service, IQR, White, Blood, Hypoglycemia, Patient, United States Congress, Medicare, Glucose, Organization, UC, Medical device

BOSTON, April 18, 2024 /PRNewswire/ -- Glytec, whose industry leading SaaS platform empowers collaborative diabetes management and insulin dosing from the hospital to the home, announces a major step forward in its advocacy and partnership efforts to drive excellence in diabetes care and a commitment to enable hospitals and providers to measure and improve outcomes for patients.

Key Points: 
  • Recently, CMS proposed the addition of two new mandatory electronic clinical quality measures (eCQMs) related to Severe Hypoglycemia and Severe Hyperglycemia for the CY 2026 reporting period.
  • The proposed rule change issued on April 10, 2024, impacts hospitals through the Hospital Inpatient Quality Reporting (IQR) program.
  • We are proud to align with industry experts, partners, clients, and CMS in supporting measures to advance diabetes care, reduce health inequities, and move beyond antiquated, paper-based solutions."
  • The mandatory measures are related to glucose and diabetes management, which have been significant challenges for the healthcare industry.

FibroBiologics Presents Data from Dermal Fibroblast Spheroid-based Treatment of Chronic Wounds in a Diabetes Mouse Model at Advanced Wound Care Summit USA

Retrieved on: 
Thursday, April 4, 2024
Diabetes, Fibroblast, EGFR, Warfarin necrosis, Risk, Communication, IL-6, Form, Diabetic foot ulcer, Conditional sentence, Patient, Research, Mouse, Gamma ray, Trial of the century, HDF, Hyperglycemia, Acceleration, Wound healing, Cytokine, Therapy, Cellular senescence, Interleukin, VEGF, Pharmaceutical industry

These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17.

Key Points: 
  • These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17.
  • Diabetic foot ulcers (DFUs) are prevalent in individuals with diabetes, with approximately 33 million people impacted globally.
  • FibroBiologics' research aims to address this issue by investigating the potential of using human dermal fibroblast (HDF) spheroids in promoting and accelerating the wound healing process in diabetic patients.
  • "These results support the potential of HDF spheroids to expedite the healing process of chronic wounds associated with diabetes," said Dr. Khoja.

Corcept Completes Enrollment in Phase 3 Gradient Trial of Relacorilant in Patients With Adrenal Cushing’s Syndrome

Retrieved on: 
Monday, April 1, 2024
Death, Adenoma, Doctor of Pharmacy, Risk, Patient, Oncology, Syndrome, Hyperglycemia, Hyperplasia, Hypertension, Pharmaceutical industry

“Hypercortisolism with adrenal etiology affects many patients and is associated with serious cardiometabolic comorbidities, including hypertension and hyperglycemia, and increased risk of premature death,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

Key Points: 
  • “Hypercortisolism with adrenal etiology affects many patients and is associated with serious cardiometabolic comorbidities, including hypertension and hyperglycemia, and increased risk of premature death,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
  • “GRADIENT is the first prospective placebo-controlled study to be conducted exclusively in these patients with Cushing’s syndrome.
  • We expect data from GRADIENT in the fourth quarter of this year.”
    GRADIENT is a randomized, double-blind, placebo-controlled trial conducted at sites in the United States, Europe and Israel.
  • One-hundred thirty-seven patients were randomized 1:1 to receive relacorilant or placebo for 22 weeks.

Alterome Therapeutics Presents Pre-Clinical Data Supporting the Development of Lead Program, an AKT1 E17K Inhibitor

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Pharmaceutical, Health, Oncology, AKT1, Mutation, Patient, Breast, Cancer, AACR, Hyperglycemia, PDX, Therapy, Pharmaceutical industry

Alterome Therapeutics, Inc. , a biopharmaceutical company pioneering the development of next generation, small molecule targeted therapies for the treatment of cancer, today reported promising preclinical data from their lead pipeline candidate, ALTA-2618, a mutation-selective inhibitor for AKT1 E17K driven cancers.

Key Points: 
  • Alterome Therapeutics, Inc. , a biopharmaceutical company pioneering the development of next generation, small molecule targeted therapies for the treatment of cancer, today reported promising preclinical data from their lead pipeline candidate, ALTA-2618, a mutation-selective inhibitor for AKT1 E17K driven cancers.
  • ALTA-2618 is an orally bioavailable, mutant-selective, and covalent allosteric inhibitor of AKT1 E17K.
  • AKT1 E17K is a clinically validated oncogene that drives cancers, including breast, endometrial, and prostate cancers.
  • “We’re excited to present data at AACR featuring Alterome’s lead program, ALTA-2618, the first AKT1 E17K-selective inhibitor.

ACELYRIN, INC. Announces Positive Phase 1/2 Proof-of-Concept Data for Lonigutamab, First Subcutaneous Anti-IGF-1R to Demonstrate Clinical Responses in Thyroid Eye Disease

Retrieved on: 
Wednesday, March 20, 2024
Oculoplastics, Patient, Private practice, Webcast, TED, Cohort, Standard of care, NEJM, MD, Graves' ophthalmopathy, Hyperglycemia, Safety, Huber loss, Orbital, Medical device

LOS ANGELES, March 20, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced positive proof-of-concept data from an ongoing Phase 1/2 trial of lonigutamab in thyroid eye disease (TED). Lonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism of action for the treatment for TED.

Key Points: 
  • There have been no reports of hyperglycemia or hearing impairment and no serious adverse events.
  • “It is very encouraging to see the results of subcutaneous administration of an anti-IGF-1R therapy.
  • The data shown suggest that there is a clinically meaningful response in patients as early as 3 weeks after a single subcutaneous dose of lonigutamab.
  • “It is important to note that this is preliminary data in a small group, however the positive results are highly promising.

ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, March 13, 2024
AXL, PIN, Neutropenia, Growth, Rituximab, Sarcoma, ALT, NSCLC, ASH, FY, Progression-free survival, Skin infection, Patient, Follicular lymphoma, S&M, Research, EDT, Aes, Periodic breathing, G&A, University, Lung cancer, Insurance, AACR, DLT, Pancreatic cancer, Hyperglycemia, Society, Therapy, Clinical trial, Diffuse large B-cell lymphoma, PFS, CD22, ADC, Data, Fatigue, MD Anderson Cancer Center, FDA, DLBCL, Marketing, PSMA, IDMC, Pharmaceutical industry

LAUSANNE, Switzerland, March 13, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates.

Key Points: 
  • “In the fourth quarter we saw results of our strategy in action across a number of key areas.
  • A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings.
  • R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022.
  • ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time.

CopilotIQ Named to Fast Company’s Annual List of the World’s Most Innovative Companies of 2024

Retrieved on: 
Tuesday, March 19, 2024
Cardiology, Software, General Health, Health, Diabetes, Artificial Intelligence, Health Technology, Technology, Blood pressure, Glucose, Editorial, Culture, Organization, Entrepreneurship, MIC, Physician, Biomarker, AI, Hope, Anomaly, Fasting, Hyperglycemia, ITunes, Most, Medicare, BMI, Nursing, Medicare Advantage, Hypertension, Human, Pharmaceutical industry

CopilotIQ , the company reshaping care for older Americans with diabetes and hypertension, has been named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2024.

Key Points: 
  • CopilotIQ , the company reshaping care for older Americans with diabetes and hypertension, has been named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2024.
  • Alongside the World's 50 Most Innovative Companies, Fast Company recognizes 606 organizations across 58 sectors and regions.
  • The World's Most Innovative Companies stands as Fast Company's hallmark franchise and one of its most anticipated editorial efforts of the year.
  • This event celebrates the Most Innovative Companies honorees and provides an inside look at cutting-edge business trends and what it takes to innovate in 2024.

INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps

Retrieved on: 
Monday, March 11, 2024
Diabetes, Senior, Randomized controlled trial, Inhalable insulin, RAA, Teaching, Hyperglycemia, MannKind Corporation, AUC, A1C, Standard of care, Conference, ATTD, Safety, University, MDI, Patient, Insulin, Automation, Clinical trial, T1D, Pharmaceutical industry

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
    INHALE-3 is a 17-week randomized controlled trial with a 13-week extension.
  • Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label.
  • For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.